“If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
Model Catalog: HT50-H1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: HT50-T (Lot serial: ALL SERIAL NUMBERS); Model Catalog: HT50-H (Lot serial: ALL SERIAL NUMBERS)
Worldwide Distribution-- USA including states of OH, VA, WA, WI and country of Turkey.
Description du dispositif
Newport HT50¿ Ventilator. Model #HT50 H1-B || The device is intended to provide continuous or intermittent mechanical ventilator support for the care of individuals who require mechanical ventilation. Specifically, the NEWPORT HT50 is applicable for adult and pediatric (i.e. infant, child and adolescent) patients, greater than or equal to 10 kg (22 Ibs), who require the following general types of ventilatory support.
EP Cases are not serialized and are not always associated with a specific ventilator serial number. The field correction applies to all Emergency Preparedness (EP) Storage Cases used to store HT 50 ventilators.
Worldwide Distribution -- USA including states of PA, TX, AK, GA, CA, MD, KY, FL, VA, LA, NC, OK and countries of Canada, Colombia, Armenia and Japan.
Description du dispositif
Newport HT50 Ventilator. || Model No. HT50-H, HT50-HB, HT50-H1, and HT50-H1B. || The device is intended to provide continuous or intermittent mechanical ventilator support for the care of individuals who require mechanical ventilation. Specifically, the NEWPORT HT50 is applicable for adult and pediatric (i.e. infant, child and adolescent) patients, greater than or equal to 10 kg (22 Ibs)